Vibro shifter is used in pharmaceuticals to crush the solid mass of granules to make the desired size of granules with the help of sieves. Let’s understand the cleaning and operation procedure of Vibro shifter.
1.0 Objective: 1.1 To lay down the procedure for Vibro Shifter operation and Cleaning
2.0 Aim: This procedure is applied to Vibro Shifter operation and Cleaning in the production department
3.0 Responsibility: 3.1 Operation: operation and cleaning as per this SOP
3.2 Officer and executive: for implementing this SOP
3.3 Manager/ Head of department: for overall compliance with this SOP
4.0 Cleaning of Vibro shifter
4.1 Fix the “To be cleaned” label on it before washing.
4.2 Switch off the power control of the equipment and the main switch.
4.3 Spillage of Water on electrical parts like motor and starters is to be avoided.
4.4 As soon as the sifting process is over, dismantle the parts of the S.S. feed hopper, S.S. frame, holding the sieve in place, and S.S. wire mesh sieve
4.5 Remove all the residual powder adhering to the wall and corners with the help of a nylon brush.
4.6 Wash all parts with the help of running 50 Liters of D.M. water followed by 20 Liters of Potable water.
4.7 Rub the parts with the help of a sponge and wash with D.M. water.
4.8 Clean the parts with D.M. water to remove all traces of the previous product and finally rinse with Potable water. Dry all parts by using air with a pressure of (2.0 kg).
4.9 Intimate IPQA to collect rinse water/swabs sample for testing as per SOP “collection of Rinse/ swab sample“.
4.10 Drain off the water and dry all the parts of the shifter with the help of an air blower.
4.11 Clean the exterior of the sifter stand and motor assembly with the help of a lint-free wet cloth.
4.12 Equipment Cleaning Testing results are performed by Q.C for complied/do not comply as per prescribed test methods.
4.13 If the test results comply, assembled the cleaned and dried parts of equipment and affix a ”Cleaned” label.
4.14 If the test results do not comply, the parts must be cleaned again carefully, and inform IPQA by rising intimation.
Note: To collect a sample for testing. Cleaning should be done until the results are obtained as desired limits.
5.0 Operation of the sifter
5.1.1 The operators should wear a nose mask, goggles, and hand gloves while handling the material.
5.1.2 The amount of material on the screen should be small so that larger particles do not obstruct the passage of small particles.
5.1.3. The motion should not be too vigorous to cause a size reduction of the particles or damage to the screen.
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6.0 Principle of Vibro shifter :
6.1 To impart horizontal rotary motion to the particle by vibration generated out of balance flywheel is done to obtain a material of uniform particle size and free from foreign particles.
7.0 Method of operation/working
7.1 Fix the suitable size S.S. screen mesh, as specified in the BMR for the individual product.
7.2 The amplitude of vibration is adjusted by the movable weight on the flywheel.
7.3 The material is poured on the mesh with a scoop.
7.4 The sifted material is collected in a clear polyethylene bag fitted in a clean container.
7.5 The dust and other particles remaining over the screen are thrown away.
7.6 Polyethylene bag is tied with a thread tightly, and the container is closed with a lid. The container is to be correctly labeled with the in-process label.
7.7 After the completion of the sifting of the material, the charging port, the wire mesh screen, and the other S.S. parts coming directly into contact with the product are cleaned as mentioned above.
7.8 The other parts of the machine are cleaned using a vacuum cleaner.
SOP: Standard operating procedure
QA: Quality assurance
QC: Quality control
IPQA: in-process quality control
S.S: Stainless steel